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Using Dupilumab to Improve Circadian Function, Sleep and Pruritus in Children With Moderate/Severe Atopic Dermatitis

ConditionsAtopic DermatitisSleep Disturbance
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age6-17
SponsorNorthwestern University

About this trial

Single center, prospective, Open label study of sleep, pruritus and circadian function pre/post 12-weeks of dupilumab treatment in children 6-17 years old

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Participants, 6-17 years old at time of enrollment.

Moderate to severe chronic AD inadequately controlled by topical treatment, diagnosed according to Hanifin and Rajka criteria by a pediatric dermatologist or allergist.

AD severity will be determined at baseline with Validated Investigator Global Assessment (vIGA) score of moderate (3) or severe (4).

Patient assessed or parent-proxy (under 8 years old) PROMIS sleep disturbance T-score ≥60.

Disqualifiers

Poorly controlled asthma (Asthma Control Test ≤19).

Self-reported sleep disturbance on 2 or more nights in the past 7 days due to allergic rhinitis.

Use of concomitant medication that causes scratching.

Major medical condition (such as cancer).

Trial design

Design model

Single group

Treatments tested in this trial

  • Dupilumab

    Drug

    12 week dupilumab administration

Treatment groups

40 Participants
are divided into 1 treatment group
Group A: Dupilumab administrationExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

PROMIS (Patient Reported Outcome Measurement Information System) parent-proxy score

Improvement from baseline in PROMIS Parent-Proxy sleep disturbance score (short format 8-item) after 12 weeks post dupilumab initiation. The minimum value is "Never" and the maximum value is "Always". Higher scores mean worse outcomes.

Time frame
12 weeks
2

PROMIS patient score

Improvement from baseline in PROMIS Patient-reported sleep disturbance score (short format 8-item) after 12 weeks post dupilumab initiation (in children ≥ 8 years old). The minimum value is "Never" and the maximum value is "Always". Higher scores mean worse outcomes.

Time frame
12 weeks
3

Wake After Sleep Onset

Percentage of patients achieving clinically significant improvement in minutes of Wake After Sleep Onset from baseline to Week 12 on inpatient polysomnography (PSG).

Time frame
12 weeks

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Northwestern University

Lead sponsor

Regeneron Pharmaceuticals

Collaborator

Source ClinicalTrials.gov
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